Recall Z-0239-2019— Philips Medical Systems Gmbh, DMC

Name: FDA recall Z-0239-2019
Creator: U.S. Food and Drug Administration
Published: 2018-09-19

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems Gmbh, DMC, initiated 2018-09-19, terminated 2023-08-10. It names one FDA 510(k) clearance: K141736. Product: Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, 712029, 712031, 712032701032, 712033, 712224, 712225, 712226, 712227, 712228.. Reason: Stitching run on SkyPlate detector interrupted intermittently; Stitching with SkyPlate aborts after first image; System software CD contains wrong baseline.

Recalling firm: Philips Medical Systems Gmbh, DMC
Classification: Class II
Status: Terminated
Initiated: 2018-09-19
Terminated: 2023-08-10
Firm location: Hamburg, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K141736 — PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOSTPhilips Medical Systems Dmc GmbH·cleared 2014-07-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, 712029, 712031, 712032701032, 712033, 712224, 712225, 712226, 712227, 712228.

Reason for recall

Stitching run on SkyPlate detector interrupted intermittently; Stitching with SkyPlate aborts after first image; System software CD contains wrong baseline

Data sourced from openFDA. This site is unofficial and independent of the FDA.